A 2024 Guide to Healthcare Compliance Regulations

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In the last few years, we are witnessing the worldwide rise of digital awareness which is bringing rapid growth to the healthcare industry. It seems like today's fast-paced lifestyle, dynamic economic standards, and limited quality time go hand in hand with digitalization, supporting these ongoing trends with a high potential in prevention and patient-centric approaches. Based on its established market and high potential for development, digitalization is already taking the lead in North America, Europe, and Pacific Asia.

The health market is expected to grow by up to 25% by 2028 globally, while the Gozio Health Survey says that 9 out of 10 consumers prefer using a single digital platform to manage their healthcare needs. Half of the respondents said they’d opt for a mobile app over a desktop or laptop to access desired features. The healthcare system worldwide may have recognized the increasing potential of digitalization but also carries enormous responsibility in delivering processes safely and ethically for its consumers. Prioritizing smart implementation of digital potential should be understood as a high priority for the industry pioneers while setting examples for small and medium-sized businesses.

When Your Software Meets Compliance Reality

A good idea deserves a well-structured development plan. A well-structured plan requires expert experience to meet the necessary standards. And when it comes to delivering healthcare software solutions and achieving defined business goals, it’s pretty much the same: delivering the best product to ensure user satisfaction and their later return.

As mentioned earlier, it’s no surprise that healthcare companies need to answer numerous standards to maintain their credibility. It’s what makes the healthcare industry function smoothly while delivering high-level security to the end user.

What Does it Mean to Be Healthcare Compliant?

Simply said, healthcare compliance means following laws and standards established in the healthcare industry.

It's your responsibility that every level of your organization follows these rules and that they are respected by every personnel involved in each stage of the development process. To be more clear, it means that you, as a stakeholder, protect patients and ensure the privacy of their data, running each step of the process with low risks of data breach, while ensuring the efficacy of your healthcare business.

To help you make sure that an expert team works on delivering your idea with the highest respect of the healthcare security regulations, we have created a guide to help you determine which standards your chosen partner needs to follow to ensure the safety of your product and its end users

HIPAA regulations

HIPAA is a well-known term among healthcare developers which stands for the Healthcare Insurance Portability and Accountability Act. HIPAA is a US law established in 1996 to enforce data security measures protecting patients’ medical information. This Act regulates the processing of protected health information (PHI) by any organization working in the US market. All information that is produced, saved, transferred, or received in an electronic form is called electronic protected health information (ePHI) and is covered under the HIPAA security law.

So, whether your medical product is being used by the entity or business associates or is accessing/storing PHI, it must adhere to HIPAA regulations. Otherwise, you’re risking facing legal consequences and compromising patient privacy and security.

To avoid panic before you even begin planning your development process, HIPAA representatives have defined technical, physical, and administrative safeguards that must be marked on your checklist.

Technical HIPAA measures

We’ll start with these measures since they are crucial for developers responsible for delivering quality software solutions. Your compliance practically depends on the way they implement these measures and on their technical understanding of what HIPAA demands.

Let's review the safeguards and understand how they can be implemented:

  1. Access control - Access to the PHI should be available to authorized personnel only. To comply with this request, using a password, PIN code, security token or key, or biometric data such as fingerprints or voice detection can be effective security options.
  2. Audit control - All actions involving PHI or data changes that may have happened must be recorded, whether through hardware, software, or procedures meant to track and record any activities in the system and audit them.
  3. Integrity control - All data must be protected from any possible damage or changes. Whether access is authorized or not it is essential to identify all possible access and develop an integrity policy. 
  4. Transmission security - To prevent unauthorized data access it is necessary to implement technical security measures while all PHI transmissions are undergoing.

Physical HIPAA measures

As the term implies, physical safeguards regulate access to your office and computer systems and control access to the project's ePHI.

Examples of required physical safeguards include:

  1. Facility access control - Ensuring that only authorized personnel have access to the facilities of a designated organization.
  2. Workstation security measures - Access to PHI-enabled devices has to be controlled. It’s commonly done through video surveillance, locks, security systems, and mobile data deletion when employees leave the organization.

Administrative HIPAA measures

If your organization uses HIPAA-compliant software on the project, these measures will define its proper management.

The measures are:

  1. Information access management - Access to the PHI needs to be ensured with minimum disclosure. Dedicated staff should access PHI only when necessary for providing services. For a dedicated development team this means building compliance software with flexible access controls.
  2. Risk analysis - It’s necessary to identify how PHI is processed and analyze potential risks. The development team should provide a software owner with a clear understanding of data usage practices.
  3. Security personnel and training - After launching the software, security should be ensured through staff training to protect the system from unauthorized access or cyber-attacks. 
  4. Data security assessment - Your organization should organize periodic security checks to ensure HIPAA compliance continuity.


This abbreviation stands for General Data Protection Regulation. It came into force in 2008 in European Union countries to protect the privacy and security of individuals' sensitive data in all sectors. The regulation protects EU citizens’ data by defining how organizations process, store, and destroy it, and it applies to them anywhere in the world.

What does this mean for the healthcare industry?

Many US organizations mistakenly believe that the GDPR doesn't affect them if they don't operate in Europe. However, the law applies to any data collected on EU citizens worldwide. Even the smallest clinic treating EU citizens must comply with GDPR rules.

When it comes to protecting healthcare data, this type of information is considered a highly protected category under the GDPR protocol. It may intersect with US healthcare regulations, such as the previously mentioned HIPAA, potentially leading to legal synchronization across borders. Taking into consideration the high demand in the development of the healthcare industry, which deals with various types of personal data, this presents an opportunity to enhance systems, policies, and processes to stay ahead of potential threats to both institutional and patient information.

According to its protocols, three types of personal data are especially important for the healthcare industry:

  • Data concerning health - Any data related to an individual's physical or mental health is considered as personal and protected data under GDPR. This includes any information related to the type of care they receive.
  • Genetic data - This considers any lab results related to an analysis of a biological sample, as well as any characteristics that might reveal details of the patient's health in general.
  • Biometric data - This is data related to someone's physical or behavioral characteristics. It includes facial images, fingerprints, and other identification data that must be protected by the GDPR since it can be used for personal identification.

Additional Security Standards

HL7 (Health Level Seven) represents internationally accepted standards that define the transfer and communication of clinical, financial, and administrative data between software applications used in healthcare.  These standards define how information is handled, starting from the packaging and communication of information between parties, to specifying the language, structure, and data types necessary for smooth integration between separate systems.

HL7 gathers all departments involved in the development process around its procedures, starting from practitioners to engineers and managers. The number seven in its name stands for seven parts, each serving a purpose and defining a new set of rules.

Next to HL7 stands its emerging and innovative standard for information exchange - FHIR, a Fast Healthcare Interoperability Resources. Created to ease the complexity of different HL7 versions, FHIR combines the best features of previous standards into a common specification, while being flexible enough to meet the needs of a wide variety of use cases within the healthcare ecosystem. 

Due to the complexity of the HL7 creating something simpler yet with similar functionality, resulted in the creation of the HL7 FHIR standard.

As the transition to FHIR has only started, currently,  both FHIR and HL7 software standards are used in healthcare software development, enabling healthcare service providers to implement the benefits of modern technology to their fullest potential.

Feeling overwhelmed by this list of procedures?

It’s understandable.

But.. first things first - when it comes to healthcare software development, there can never be too much of care, caution, or security measures. It is all about choosing the right tools and measures and setting the field for an easygoing development process.

In case you’re having trouble doing it all on your own, you can gather a team of experts experienced in developing and managing projects that require the above-mentioned specter of procedures. This way you will have time to concentrate on the core of your project and achieving the goals you set at the start.

If you’re already considering an outsourcing partnership model, Inviggo could be your ideal choice. With our wide experience in delivering healthcare solutions for more than 3 years, we can provide you with highly experienced HIPAA-certified healthcare professionals.

This article is written by Tatjana Štricki
Photo by
Anete Lusina

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